The instant low profile, pivoting joint infusion assembly transports therapeutic fluids, such as insulin, from a remote, external source to a subcutaneous location in a patient's body with little or no leakage of fluids. The therapeutic fluid passes from the source, through a delivery tube, to a fluid infusion connection unit removably attachable to a therapeutic fluid infusion unit designed to be affixed to the patient's skin. The fluid infusion unit has a cannula insertable approximately normal to the skin to subcutaneously deliver the therapeutic fluid within the patient.
As is well known in the art, the cannula is generally a hollow, soft, flexible member which enters the skin through a passageway formed by a hollow sharp-tipped, insertion needle. The insertion needle pierces the skin and subcutaneous regions of the infusion site allowing the cannula to pass therethrough. The needle is removed and properly disposed. Once the fluid infusion unit is connected to the patient, it generally remains in position. The connector assembly may be attached/detached as necessary to replace or change the therapeutic fluid being administered.
In the various embodiments of the present invention, a rotating member ensures accurate, positive alignment of fluid paths through the connection unit and the infusion unit.
Numerous approaches have been taken to provide quick-disconnect system for infusion therapy. U.S. Pat. Nos. 5,545,143 and 6,017,328 to Fishell disclose and teach such prior art systems. However, there are considerable drawbacks to the prior art systems; namely, the high cost of manufacturing an integral septum system within the main body or fluid infusion unit and the necessity for removably attaching the connector assembly through the top surface of fluid infusion unit, thereby creating a higher profile for the entire infusion assembly when worn by the patient. It is well known that the higher the assembly's profile the more likely the assembly may be disturbed, exposed to unintentionally external contact, and dislodgment from the infusion site. Further, to ensure a leak-free infusion system, it is critical that there be positive alignment of the fluid infusion unit and the fluid connection assembly.
The various embodiments of the present invention solve the long-standing problems of the prior art devices. They achieve improved infusion therapies by, among other things, providing a safe, low-profile assembly wherein the therapeutic fluids may be administered, replaced, and changed quickly, securely, and confidently in an extremely low-damage exposure arrangement with little or no leakage of the therapeutic fluids to the environment.